Implant rehydration packages and methods of use

ABSTRACT

Packages for the rehydration of implants are described, wherein the package may contain a first chamber containing a rehydration fluid, a second chamber containing an implant, and a barrier configured to be affected without compromising the sterility of the package. The rehydration fluid may engage and rehydrate the implant after the barrier is ruptured. Methods of use are also described.

FIELD OF THE INVENTION

The inventive packages and methods generally relate to the field of implants for use in the body, and the packaging, storing, and rehydration of the implants.

BACKGROUND OF THE INVENTION

Many spinal fusion implants are made of human bone, and may take the form of autografts (the patient's bone), allografts (another human's bone), xenografts (non-human species' bone), synthetic implants, or combinations thereof. These implants, especially allografts, are often freeze-dried to extend the useful shelf life of the implant. For optimal performance of the implant during surgical implantation, it is highly recommended that an implant, previously freeze-dried, be hydrated prior to implantation. Such hydration may take place in a saline solution, or any number of known rehydration materials. Implants that are not rehydrated prior to implantation are prone to fracture due to the loads applied during surgical insertion and/or impaction.

While the general materials and procedures for forming, freeze-drying, rehydrating, and inserting spinal implants is generally known, there exists a need to simplify the rehydration materials and methods. Currently, freeze-dried implants are delivered to an operating room in a single-piece sterilized package, or a double-packed sterilized package, having a sterile inside, but a non-sterile outside. The implants must be removed form the packaging and thereafter placed in an open container of rehydrating fluid for rehydration prior to use. There exists a need for materials and methods for making the rehydration process more sterile, simple, and convenient.

SUMMARY OF THE INVENTION

A package for rehydrating an implant is described, comprising: a first chamber containing a rehydration fluid; a second chamber containing an implant; a seal in communication with at least a portion of the first and second chambers; wherein the first and second chamber are at least partially separated by a barrier, the barrier configured to be affected; and wherein after the barrier is affected, at least a portion of the rehydration fluid is able to engage the implant without detaching the seal.

The first chamber may have a first pressure and the second chamber may have a second pressure, and wherein before the barrier is affected, the first pressure may be greater than the second pressure.

The implant may be an allograft, autograft, xenograft, or may be at least partially comprised of a synthetic material.

The barrier may be configured to be affected by external load or pressure. The barrier may be configured to be affected by at least one protrusion. The barrier may be configured to be affected by axial strain.

The package may further comprise a third chamber. The first chamber may further contain a pouch, and wherein the rehydration fluid may be enclosed in the pouch. The barrier may be a portion of the pouch.

A method of rehydrating an implant is also described, comprising the steps of: (a) providing a package for rehydrating an implant, comprising: a first chamber containing a rehydration fluid; a second chamber containing an implant; a seal in communication with at least a portion of the first and second chambers; wherein the first and second chamber are at least partially separated by a barrier; (b) affecting the barrier, thereby permitting at least a portion of the rehydration fluid to enter the second chamber; (c) permitting the rehydration fluid to contact the implant; (d) detaching at least a portion of the package to expose the implant for retrieval by a user; and (e) removing the implant from the package.

Step (d) may involve detaching the entire seal. The implant in step (a) may be freeze-dried. The first chamber may be supplied under a higher pressure than the second chamber. The barrier may be ruptured.

BRIEF DESCRIPTION OF THE DRAWINGS

While preferred features of the present invention may be disclosed in the accompanying illustrative, exemplary drawings, for the purposes of description, the invention as defined by the claims should be in no way limited to such preferred features or illustrative and exemplary drawings, wherein:

FIG. 1A is a top view of an embodiment of a rehydration package including rehydration fluid and a freeze-dried implant;

FIG. 1B is a cross-sectional view of the package of FIG. 1A taken along the line A-A;

FIG. 1C is a top view of the package of FIGS. 1A-1B, after the barrier has been affected, but before the fluid has engaged the implant;

FIG. 1D is a top view of the package of FIG. 1C, after the fluid has engaged the implant, enlarging the implant into a rehydrated state;

FIG. 2 is a side view of another embodiment of a rehydration package having a fluid pouch able to be affected by a depressible button;

FIG. 3A is a side view of yet another embodiment of a rehydration package having a sharpened spike configured to affect the barrier upon actuation by a depressible button;

FIG. 3B is a side view of still another embodiment of a rehydration package having a T-bar configured to affect the barrier upon actuation by a depressible button; and

FIG. 4 is a side view of a further embodiment of a rehydration package having a barrier able to be affected by flexing of the package.

DETAILED DESCRIPTION OF THE INVENTION

It is initially noted that while some of the packaging, implants, and methods herein are described with reference and application to the spine, it will be appreciated that features of the packaging, implants, and methods and the packaging, implants, and methods themselves may have other applications, and can be applied to other bones and/or parts of the skeleton. For instance, the implant may be a ligament to be used in a knee, elbow, wrist, or shoulder procedure. Further applications are expressly considered as well.

FIGS. 1A-1D show several views of an embodiment of a rehydration package 10, and an exemplary method of use. As seen in FIG. 1A, a rehydration package 10 may have an outer layer 12 and an inner layer 14. In embodiment shown in FIG. 1A, the relative distance between outer and inner layer 12, 14 is exaggerated to show detail. It may be preferable to have an inner layer 14 surrounded by an outer layer 12 at least for the fact that even if outer layer 12 is breached, inner layer 14 and the contents of the package 10 may still remain sterile. In this sense, outer layer 12 may simply serve as an added layer of protection for inner layer 14 and the contents of package 10. Outer and inner layer 12, 14 may or may not be comprised of the same materials, and may or may not have substantially the same thicknesses. It may be preferable to have an outer layer 12 comprised of a relatively stronger, thicker, and more resilient material than inner layer 14, for at least the reasons discussed above. Outer and inner layers 12, 14 may be joined by a perimeter wall 28.

It is also contemplated that outer and inner layers 12, 14 may also be opposite sides of a package wall of package 10. In that sense, outer and inner layers 12, 14 may be integral with a common wall, with a thickness therebetween equal to the thickness of the wall.

Rehydration package 10 also may have a first chamber 20 and a second chamber 22, which may be at least partially separated by a dividing wall 16. The embodiment of FIG. 1A has two chambers 20, 22. However, more than two chambers may be appropriate, depending at least in part on the contents of the package 10, and the desired interaction of the contents within the package 10.

At least a portion of dividing wall 16 may comprise a barrier 30, which may be configured to be affected by several suitable methods and devices, discussed in more detail below. Moreover, the entire dividing wall 16 may be a rupturable barrier 30. Barrier 30 may be comprised of a material of suitable strength and/or thickness upon which a rupture of desired shape may be possible. For instance, if a relatively small rupture is desired, it may be beneficial to have a relatively strong and/or thick barrier 30. Barrier 30 should not be porous.

Barrier 30 may be made of a material compatible with the contents of package 10. More importantly, the material or materials comprising barrier 30 should not interfere with the desired content interaction of the package 10 after the barrier has been affected. For instance, if a portion of barrier 30 is dislodged and/or fractured during the rupturing process, it is preferable that the affected portions of barrier 30 do not interfere with any desired processes or contents of the package 10 thereafter.

In the embodiment shown in FIG. 1A, first chamber 20 contains rehydration fluid 24. As seen in cross-sectional view FIG. 1B, fluid 24 may substantially or only partially fill first chamber 20. Fluid 24 may be placed under a first pressure P₁ within the first chamber 20. Fluid 24 may contain more than one ingredient and/or substance. Fluid 24 may comprise water, saline solution, medicines, antibiotics, blood, bone marrow aspirate, platelet concentrate, bore morphogenic proteins, and/or bone growth stimulators. Other ingredients and/or substances comprising rehydration fluid 24 are expressly contemplated, as will be understood by those skilled in the art.

FIG. 1A also shows a package 10 having a second chamber 22 containing a freeze-dried implant 26. The implant 26 shown in FIG. 1A is a bone allograft, but other types of implants are expressly contemplated for use with rehydration package 10. Freeze-drying methods and materials of implant 26 are well-known in the art. Implant 26 may be placed under a second pressure P₂ within the second chamber 22.

Package 10 may also have a seal 18 overlying the chambers 20, 22. Seal 18 is shown in FIG. 1A as transparent for clarity. Seal 18 may be attached to the perimeter wall 28, dividing wall 16, and/or barrier 30. It may be preferable for seal 18 to be a thin, transparent layer, that is heat-sealed onto substantially all of the perimeter wall 28 and accessible portions of the dividing wall 16 and barrier 30, so as to create a sterile environment for the contents of package 10. It may also be preferable for seal 18 to be attached to perimeter wall 28, dividing wall 16, and barrier 30 such that the seal 18 remains adhesively attached to the package 10 during transportation, storage, heating, cooling, and/or activation of the package 10. Moreover, it may further be preferable that seal 18 be adhesively attached to package 10 such that a user may at least partially remove seal 18 from package 10 without undue exertion, and without damaging the integrity of the other components and contents of the package 10. In summary, seal 18 should be made and applied in such a way that it maintains the sterility and integrity of the package 10, and is removable from the package 10 upon the desire of the user.

Package 10 may also be enclosed in an outside package (not shown), which may contain labeling and other information. In use, package 10 may be removed from outside package before rehydrating an implant 26. Enclosing package 10 in an outside package may be beneficial in that the outside package may provide another barrier to keep package 10 sterile, such that the sterility of the outside package may be compromised without compromising the sterility of the package 10.

FIG. 1B shows a cross-sectional side view of the rehydration package 10 embodiment of FIG. 1A. In this embodiment, seal 18 is attached to both the perimeter wall 28 and barrier 30. Seal 18 also may have excess material beyond the perimeter wall 28 to allow a user to grasp the seal 18 and subsequently remove it.

FIGS. 1C-1D show representative stages of an embodiment of a rehydration package 10 in use. In the embodiment shown in FIGS. 1A-1D generally, it is an objective of the package 10 to provide a sterile environment to selectively introduce a rehydrating fluid 24 with a freeze-dried implant 26. To serve that end, barrier 30 may be affected to allow fluid 24 from the first chamber 20 to enter the second chamber 22 and engage the implant 26. FIG. 1C shows the rupture of barrier 30, before fluid 24 has entered the second chamber 22. The arrow indicates the anticipated movement of at least a portion of the fluid 24.

The movement pattern and tendency of fluid 24 from the first chamber 20 to the second chamber 22 may be altered by variations of pressures P₁ and/or P₂. For instance, it may be preferable to increase P₁ beyond normal atmospheric pressure so that P₁ is greater than P₂. P₁ may be artificially increased by introducing nitrogen or another inert gas to the first chamber 20. This may be achieved by way of a valve port (not shown) associated with first chamber 20, or other equivalent structure. It may be beneficial to have P₁ greater than P₂, so that when barrier 30 is affected, fluid 24 in first chamber 20 will immediately seek the lower pressure area of the second chamber 22 containing implant 26. This arrangement may therefore reduce total rehydration time. Similarly, P₂ may be artificially reduced in comparison to P₁ by creating a vacuum in the second chamber 22. The raising of P₁ and the reducing of P₂ may also be done in combination to produce a desired disparity between the pressures of the first and second chambers 20, 22.

FIG. 1D shows the embodiment of a rehydration package 10 of FIG. 1C after fluid 24 has flooded the second chamber 22 and rehydrated implant 26. By way of comparison, implant 26 in this embodiment has increased in size from its freeze-dried state in FIGS. 1A and 1C to its rehydrated state in FIG. 1D. The change in size of implant 26 is exaggerated to show detail in this illustration.

Once implant 26 has been rehydrated to a satisfactory level, seal 18 may be at least partially removed so that implant 26 may be removed from package 10, and is ready for implantation into a body. The package 10 should thereafter be discarded, as it may no longer be operable or sterile.

Whether or not an implant 26 has been rehydrated to a satisfactorily level may be dependent upon several factors, including but not limited to, the size and shape of the implant, the intended use of the implant, the characteristics of the rehydration fluid, the size of the package itself, and other particulars. A satisfactory level may be partially rehydrated or fully rehydrated. One skilled in the art will appreciate that the various levels of rehydration that may be satisfactory depending on one or more of the factors discussed above.

FIG. 2 shows a side view of another embodiment of a rehydration package 10, also having an outer layer 12, inner layer 14, seal 18, perimeter wall 28, and first and second chambers 20, 22. In this embodiment, dividing wall 16 does not extend to the lower barrier of the inner layer 14, thereby leaving a space. First chamber 20 may have fluid 24 contained in a pouch 40. This may be beneficial, among other reasons, to provide an additional safeguard of sterility.

Pouch 40 may be able to affected by use of a depressible button 50 formed in the outer layer 12. When depressible button 50 is depressed by a force (shown in the direction of the arrow), the inner layer 14 may place pressure on the pouch 40, causing outlet 42 to be affected, and releasing fluid 24 into the second chamber 22 to engage implant 26. Pouch 40 may be pressurized, as described above. Pouch 40 may also be made of material suitable for contact with fluid 24, and may be made of the same material as inner layer 14. Outlet 42 generally should be of a weaker structural strength and/or thinner material than that of the remainder of pouch 40, so that fluid 24 will exit the pouch adjacent to the second chamber 22. Moreover, the package 10 shown in FIG. 2 may have any or all of the applicable characteristics discussed supra generally or in relation to FIGS. 1A-1D.

FIGS. 3A-3B show side views of another embodiment of a rehydration package 10 also having an outer layer 12, inner layer 14, seal 18, perimeter wall 28, barrier 30, and first and second chambers 20, 22. In these embodiments, at least one protrusion may be applied to the inner layer 14 adjacent to a depressible button 50. The protrusion may be a spear 44 (see FIG. 3A), a T-bar (see FIG. 3B), or other suitable shape and/or structure.

Barrier 30 may be affected by the urging of the protrusion in the direction of the arrow by way of the depressible button 50. Preferably, the protrusion may not be urged so far as to engage and/or damage the implant 26. As discussed above, the first chamber 20 containing fluid 24 may be pressurized. Moreover, the packages 10 shown in FIGS. 3A-3B may have any or all of the applicable characteristics discussed supra generally or in relation to FIGS. 1A-1D.

FIG. 4 shows a side view of yet another embodiment of a rehydration package 10 again having an outer layer 12, inner layer 14, seal 18, perimeter wall 28, barrier 30, and first and second chambers 20, 22. In this embodiment, first and second chambers 20, 22 are more particularly defined by the shape of the outer and inner layers 12, 14. First and second chambers may also be separated by a channel 32.

Barrier 30 may be rupturable by the flexing of package 10 in the direction of the arrows. The flexing of the package 10 in this way may place a sufficient strain on the barrier 30 to affect at least a portion of the barrier 30. It may be preferable in this embodiment to place the first chamber 20 under a sufficient pressure P₁ to urge a sufficient amount of fluid 24 through the channel 32 and into the second chamber 22 to engage implant 26. Moreover, it may be necessary to orient the package 10 after the barrier 30 is affected to allow fluid 24 to flow through the channel 32 into second chamber 22.

It also may be preferable for the seal 18 in this embodiment to be flexible and/or fitted with a sufficient element of slack. When package 10 is flexed, the pivoting forces may exert strain on the seal 18. It would be undesirable for the seal 18 to rip and/or be removed as a result of this strain. Therefore, it may be necessary to create seal 18 out of a sufficiently flexible material to resiliently withstand the strain, or it may be necessary to fit the seal 18 on the package in such a way that it allows the seal to utilize sufficient slack to sufficiently account for the strain. Again, the packages 10 shown in FIG. 4 may also have any or all of the applicable characteristics discussed supra generally or in relation to FIGS. 1A-1D.

The outer and inner layer 12, 14, and dividing wall 16 may be comprised of any suitable material, including but not limited to polypropylene (PP), polyethylene (PE), Tyvek, thermal films, poly bags, PVC, aluminum foil, foil laminates, vacuum pouch, polystyrene (PS), flexible plastic packaging materials, ABS (polyacrylonitrile/co-butadine/co-styrene), PET (polyethylene terephthalate), thermoplastic elastomers, and/or combinations thereof. As stated above, it may be preferable to have the outer and inner layers 12, 14 comprised of different materials. The seal 18 may be made of sealing tape, adhesives, or the result of heat welding.

As discussed previously, at least a portion of the barrier 30 may be configured to be affected. Materials such as polypropylene (PP), polyethylene (PE), Tyvek, thermal films, poly bags, PVC, aluminum foil, foil laminates, vacuum pouch, polystyrene (PS), flexible plastic packaging materials, ABS (polyacrylonitrile/co-butadine/co-styrene), PET (polyethylene terephthalate), thermoplastic elastomers, and/or combinations thereof, may be suitable for comprising barrier 30.

This written description sets forth the best mode of the claimed invention, and describes the claimed invention to enable a person of ordinary skill in the art to make and use it, by presenting examples of the elements recited in the claims. The patentable scope of the invention is defined by the claims themselves, and may include other examples that occur to those skilled in the art. Such other examples, which may be available either before or after the application filing date, are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.

While the invention has been shown and described herein with reference to particular embodiments, it is to be understood that the various additions, substitutions, or modifications of form, structure, arrangement, proportions, materials, and components and otherwise, used in the practice and which are particularly adapted to specific environments and operative requirements, may be made to the described embodiments without departing from the spirit and scope of the present invention. Accordingly, it should be understood that the embodiments disclosed herein are merely illustrative of the principles of the invention. Various other modifications may be made by those skilled in the art which will embody the principles of the invention and fall within the spirit and the scope thereof. 

1. A package for storing and rehydrating an implant, comprising: a first chamber containing a rehydration fluid; a second chamber containing an implant; a barrier separating at least a portion of the first and second chambers, the barrier configured to be affected; a seal in communication with at least a portion of the first and second chambers; and wherein after the barrier is affected, at least a portion of the rehydration fluid is able to engage the implant without detaching the seal.
 2. The package of claim 1, wherein the first chamber has a first pressure and the second chamber has a second pressure, and wherein before the barrier is affected, the first pressure is greater than the second pressure.
 3. The package of claim 1, wherein the implant is an allograft.
 4. The package of claim 1, wherein the implant is an autograft.
 5. The package of claim 1, wherein the implant is a xenograft.
 6. The package of claim 1, wherein the implant is at least partially comprised of a synthetic material.
 7. The package of claim 1, wherein the barrier is configured to be affected by external load or pressure.
 8. The package of claim 1, wherein the barrier is configured to be affected by at least one protrusion.
 9. The package of claim 1, wherein the barrier is configured to be affected by axial strain.
 10. The package of claim 1, further comprising a third chamber.
 11. The package of claim 1, wherein the first chamber further contains a pouch, and wherein the rehydration fluid is enclosed in the pouch.
 12. The package of claim 11, wherein the barrier is a portion of the pouch.
 13. A method of rehydrating an implant, comprising the steps of: (a) providing a package for storing and rehydrating an implant, comprising: a first chamber containing a rehydration fluid; a second chamber containing an implant; a barrier separating at least a portion of the first and second chambers; and a seal in communication with at least a portion of both the first and second chambers; (b) affecting the barrier, thereby permitting at least a portion of the rehydration fluid to enter the second chamber; (c) permitting the rehydration fluid to contact the implant; (d) detaching the seal from at least a portion to expose the implant for retrieval by a user; and (e) removing the implant from the package.
 14. The method of claim 13, wherein step (d) involves detaching the entire seal.
 15. The method of claim 13, wherein the implant in step (a) is freeze-dried.
 16. The method of claim 13, wherein in step (a) the first chamber is supplied under a higher pressure than the second chamber.
 17. The method of claims 13, wherein the barrier in step (b) is ruptured. 